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Use Case: Electronic Submissions Review

This organization, a major life sciences regulatory authority in the United States, sought to transform its submission review operations in order to respond more quickly to emerging scientific, technological, and economic trends.

Business Problem

The organization wanted to increase employee productivity and accountability, while also providing them with more accurate and timely data for more informed business decisions. The organization’s processes were mostly paper-based and tended to be localized within branches, divisions and specific product-type areas. Data for review was stored in text documents, making uncovering specific information difficult. Document sharing was done largely via a legacy application tool and shared network drives. In addition to impacting performance, the environment also made training new reviewers difficult.

Appian Solution

Using Appian, the organization created a digital review application for handling submissions of 510K applications for premarket authorization requests of medical devices. The application integrates with existing systems to unify technology, bringing functionality of legacy systems up to modern day expectations while leveraging existing investments. The result is a consistent, repeatable, and standardized process that uses automation to increase data quality.

As 2019 kicks off, it’s safe to say there are going to be a few trends leading the way in the digital health space. When you look across the board at these trends, the majority have a common theme: Improving Patient and Member Outcomes.

As pressure mounts to deliver more strategic value, oil and gas CIOs must rethink operating models and IT capabilities to have the agility, speed, and innovation that is required to deploy digitalization at enterprise scale.

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Appian provides a low-code development platform that accelerates the creation of high-impact business applications. Many of the world’s largest organizations use Appian applications to improve customer experience, achieve operational excellence, and simplify global risk management and compliance.